Webinar: Real-World Approaches to Informed Consent under the Revised Common Rule

Wednesday, October 23 | 1:00-2:15 PM ET

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Overview

As the end of the first year of the revised Common Rule era approaches, it’s time for a check-in: how is the human subjects research oversight community doing so far with the new requirements? In particular, how have we acclimated to the revised Common Rule’s implications for informed consent? Many institutions have incorporated the new requirement for a summary of key information to assist potential research subjects in understanding the reasons why they might or might not want to participate in a study. There is less clarity, however, around other items, including return of research results and future use of identifiable data and biospecimens.

In lieu of official guidance, learning from one another is paramount. During this webinar, three panelists will share insights related to their institutional policies and procedures in this area. Join us to discuss successes, challenges, and lessons learned.

Agenda

  • Overview of the informed consent requirements in the revised Common Rule
    • New requirements and proposed benefits
    • Challenges that were anticipated prior to the implementation date
    • Broader implications of these requirements for policy and institutional practices
     
  • Real-world experiences from three institutions pertaining to the key information summary
    • New consent form language, training, reception by research subjects, new policies, and future plans
     
  • Challenges and questions pertaining to return of results and future use of identifiable data and biospecimens
  • Q&A

What will I learn?

After attending this webinar, you will be able to:

  • Describe current challenges, successes, lessons learned, and innovations pertaining to the new informed consent requirements in the revised Common Rule
  • Identify strategies that could benefit your organization in adapting to the regulatory changes

Who should attend?

The intended audience for this webinar is IRB and HRPP personnel, including institutional leaders of these groups. Research personnel and others in research administration may also benefit from attending.

Continuing Education

Webinar participants holding the Certified IRB Professional (CIP®) credential may apply 1.25 continuing education credits towards CIP recertification. Learn More »

Speakers

Karen BlackwellKaren Blackwell, MS, CIP developed and directs the HRPP at the University of Kansas Medical Center (KUMC). Accredited since 2007, this program integrates all facets of human research protection, including Common Rule requirements, Health Insurance Portability and Accountability Act (HIPAA), conflict of interest, safety compliance, and data and safety monitoring. Ms. Blackwell maintains leadership roles on the KUMC Clinical and Translational Science Awards and Patient-Centered Outcomes Research Institute network grants and serves as a SMART IRB Ambassador. Prior to developing the HRPP, Ms. Blackwell developed compliance programs for the HIPAA Privacy Rule and for an umbrella research compliance program.

Patrick HerbisonPatrick Herbison, MEd, CIP is assistant director of compliance in the Office of Human Research at Jefferson. He works with clinical researchers helping them to attain the highest level of Good Clinical Practice (GCP) compliance. Pat believes that the best way to achieve this is ergonomic compliance—that is, a system that easily fits the job being done. He has reviewed more consent forms than you can imagine, and has developed consent templates for a large pharmaceutical company and Jefferson. Recently Pat incorporated the new Common Rule revisions into Jefferson’s policies and forms. Pat is a Certified IRB Professional (CIP) and holds a BS in biology education and a master’s degree in education (MEd). He has been working in clinical research and compliance for 20 years.

Ann JohnsonAnn Johnson, PhD, MPH is the director for the IRB at the University of Utah and has been with the organization since 2006. She is an expert in human subjects research requirements and regulations. She has been a leader in establishing a single IRB process for the University of Utah, as well as the National Center for Advancing Translational Sciences (NCATS)-funded Trial Innovation Network. Dr. Johnson is an active member of the research community, not only reviewing and auditing proposals for the IRB, but also having conducted research and public health interventions in the United States and abroad. She has taught undergraduate- and graduate-level courses and is instrumental in continuing research education for the University of Utah, providing instruction on consent form models, establishing data and tissue repositories, investigator-initiated clinical trials, and managing reportable events.

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HRP Consulting Group

HRP Consulting LogoHRP Consulting Group provides expert advice to institutions seeking to develop or improve all aspects of their human research protection program. For more information, please visit www.thehrpconsultinggroup.com.

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Additional Resources

A collection of relevant readings accompany each PRIM&R webinar. Groups that register for webinars receive a discussion guide containing thought-provoking questions and facilitation tips to help facilitate use of the webinar as an educational tool for IRBs.

Fees

If you are not yet a PRIM&R member, we encourage you to join today, and take advantage of your very first membership benefit immediately: a discounted registration fee to this webinar.

Individual rates
Member $145
Nonmember $200
Group rates
Member $325
Nonmember $400

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